Elan Drug Technologies

Thursday 18 March 2010

Elan Drug Technologies Announces Pivotal Phase 3 Trial for Hydrocodone Controlled Release Fomulation by its Licensing Partner Zogenix Inc

DUBLIN, IRELAND, March 18, 2010, Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today announced that Zogenix Inc, its licensing partner, has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen. ZX002 which was developed using Elan Drug Technologies SODAS® technology is being studied for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.  At present there are no products available with hydrocodone only, or with controlled-release formulations in the United States.  Using Elan Drug Technologies proprietary SODAS® technology, ZX002, offers a unique controlled-release profile which utilises both immediate release and extended release properties designed to enable twice daily dosing.

 

“We are delighted to see the initiation of Phase 3 trials for this much needed treatment in patients with moderate to severe pain,” announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. “We look forward to ZX002 progressing successfully through clinical trials and seeing it being manufactured in our DEA approved site in Gainesville, Georgia in the US.”

 

The ZX002 Phase 3 clinical trial is designed to enroll approximately 600 patients with chronic low back pain. The trial is a US-based multi-center, randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of ZX002.

 

This product could potentially allow for less frequent dosing with a customised controlled-release profile and the ability to titrate to higher hydrocodone doses than currently recommended for hydrocodone products burdened by combination formulations. ZX002 treatment in chronic pain could possibly avoid some of the serious side effects associated with the use of combination opioids that contain acetaminophen, or non-steroidal anti-inflammatory drugs (NSAIDs).

 

About Elan Drug Technologies

Elan Drug Technologies (EDT) a leader in drug delivery is a business unit of Elan Corporation, plc (NYSE:ELN). EDT developed the controlled release formulation of hydrocodone, using one of its Oral Controlled Release Technologies, the SODAS® (Spheroidal Oral Drug Absorption System) technology. Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions. Products enabled by EDT technologies are used by millions of patients each day.  More information is available at www.elandrugtechnologies.com

 

About Zogenix
Zogenix, Inc., with offices in Emeryville and San Diego, Calif., is a privately held pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. The company is commercially focused on SUMAVEL™ DosePro™ (sumatriptan injection) needle-free delivery system, which launched in January 2010. The company’s pipeline includes ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain, which entered Phase 3 clinical trials in March 2010.  Zogenix also plans to license the patented DosePro needle-free drug delivery system to other companies. For additional information, please visit www.zogenix.com.

 

SODAS is a registered trademark of Elan Pharma International Ltd

 

Safe Harbour/Forward-Looking Statements
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Source: Elan Corporation, plc

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